Laser-1st vs Drops-1st for Glaucoma and Ocular Hypertension (LIGHT)

Health-Related Quality of Life in Two Pathways for Newly Diagnosed Open Angle Glaucoma and Ocular Hypertension: an Unmasked, Multi-centre, Randomised Controlled Trial of Initial Selective Laser Trabeculoplasty Versus Medical Therapy

This is a randomized study with two treatment arms: 'initial Selective Laser Trabeculoplasty (SLT) followed by conventional medical therapy as required' ('Laser-1st') and 'medical therapy without laser ('Medicine-1st'). It compares quality of life in the two arms at three years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus Medicine-1st.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Intervention / Treatment: Procedure: Primary Selective Laser Trabeculoplasty Treatment Pathway; Drug: Primary Medical Treatment Pathway

Detailed Description

Subjects are randomly allocated to one of two treatment arms that examine treatment pathways, rather than comparing single treatments alone: 'initial Selective Laser Trabeculoplasty (SLT) followed by conventional medical therapy as required' ('Laser-1st') and 'medical therapy without laser ('Medicine-1st'). We compare quality of life in the two pathways (arms) over three years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus Medicine-1st.

A 'Treat in Pursuit of Control' design (TPC) compares two different routes to a pre-defined target Intraocular pressure (IOP) (pathways). It is a pragmatic study that uses published guidelines to make the complex clinical treatment choices faced in managing glaucoma, standardised between treatment arms by use of computer treatment algorithms. A UK National Institute for Health and care Excellence (NICE)-compliant evidence-based IOP Treatment Target 1 is set for each patient, according to the study treatment algorithms. They then proceed through stepped increments of treatment intensity (up to and including surgery) until a predetermined Target IOP is reached. Target IOP is reassessed in the light of objective clinical evidence of stability of glaucomatous optic neuropathy (GON) and visual function using visual field tests and automated optic nerve evaluation. Health Related Quality of Life (HRQL) and secondary outcomes are compared for patients in each pathway.

• Study Type: Interventional
• Enrollment (Actual): 718
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of open angle glaucoma (defined as an open drainage angle and reproducible glaucomatous visual field defects as tested by the Swedish Interactive Threshold Algorithm (SITA) algorithm on the Humphrey Visual Field or glaucomatous optic neuropathy)
• OR
• Ocular hypertension (intra-ocular pressure above 21mmHg and requiring treatment as per National Institute of Health and Care Excellence (NICE) Guidelines).
• Able to provide informed consent.

Exclusion Criteria:

• Advanced glaucoma in the potentially eligible eye as determined by Early Manifest Treatment Guidelines (EMGT) criteria 77: visual field loss mean deviation worse than -12dB in the better or -15dB in the worse eye.
• Secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis, trauma etc) or any angle closure.
• Any contra-indication to selective laser trabeculoplasty (e.g. unable to sit at the laser-mounted slit-lamp; past history of uveitis).
• Unable to use topical medical therapy due to e.g. physical infirmity and a lack of carers able to administer daily eye-drops.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 'Laser-1st'; Initial Selective Laser Trabeculoplasty (SLT) [PROCEDURE] followed by conventional medical therapy (eye-drops) as required. All participants in this arm start their treatment pathway with SLT. If this does not reach the predefined, patient-specific target IOP then repeat laser (once only) is given. If the IOP target is then not reached additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy with mitomycin C) as needed.	Procedure: Primary Selective Laser Trabeculoplasty Treatment Pathway; Primary Selective Laser Trabeculoplasty Treatment (followed by medications as required) Pathway. First treatment is SLT, 100 shots of laser over 360 degrees. If this does not reach the target IOP then repeat laser (once only) is given. If IOP not at target additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy ). All available medical treatments (eye-drops) are permitted according to a pre-specified intervention protocol described in detail in the publicly available trial protocol. This begins with prostaglandin analogues, then beta-blockers followed by alpha agonists or carbonic anhydrase inhibitors. The full range of available doses, treatments and drugs is beyond this short summary.; Other Names: SLT; "Laser First"
ACTIVE_COMPARATOR: Medicine-1st; Conventional medical therapy [DRUG] without laser. All participants in this arm start their treatment pathway medical treatment. If the IOP target is then not reached, additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy with mitomycin C) as needed. During this pathway of treatment all commercially available medical treatments (eye-drops) are permitted according to a pre-specified step-wise intervention protocol described in detail in the publicly available trial protocol. This begins with prostaglandin analogues, then beta-blockers followed by alpha agonists or carbonic anhydrase inhibitors. The full range of available doses, treatments and drugs is beyond this short summary.	Drug: Primary Medical Treatment Pathway; Primary Medical Treatment Pathway (multiple medications, as required). If IOP not at target additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy ). All available medical treatments (eye-drops) are permitted according to a pre-specified intervention protocol described in detail in the publicly available trial protocol. This begins with prostaglandin analogues, then beta-blockers followed by alpha agonists or carbonic anhydrase inhibitors. The full range of available doses, treatments and drugs is beyond this short summary.; Other Names: Conventional medical therapy; "Medicine First"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life using EQ-5D	Quality Adjusted Life Years by EQ-5D health states	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life using GUI	Glaucoma-specific treatment-related quality of life: Glaucoma Utility Index (GUI)	3 years
Cost-effectiveness ratio	Incremental Cost Effectiveness Ratio	3 years
Cost-effectiveness	Cost per Quality Adjusted Life Year (QALY)	3 years
Glaucoma Symptom Score (GSS)	Disease and treatment-related symptom score (patient reported outcome, PROM)	3 years
Glaucoma Quality of Life-15 (GQL-15)	Patient Reported Visual Function Score (patient reported outcome, PROM)	3 years
Glaucoma Utility Index (GUI)	Disease-Specific Utility Score (patient reported outcome, PROM)	3 years
Visual Acuity	Visual Function measured using LogMAR acuity.	3 years
Humphrey Visual Field Assessments	Visual Function measured using Mean Deviation	3 years
Heidelberg Retinal Tomographie optic nerve analysis	Optic nerve structure, measured in mean near-retinal rim width.	3 years
Goldmann Applanation Tonometry measured intra-ocular pressure	Clinical outcome of intra-ocular pressure lowering, mmHg.	3 years
Hospital visit frequency	Objective measures of treatment pathway efficacy, measured by number of hospital visits in two treatment arms over trial period.	3 years
Treatment intensity	Objective measures of treatment pathway efficacy, measured by number of medications used in two treatment arms over trial period.	3 years

Collaborators and Investigators

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Gus Gazzard, MA FRCOphth, Moorfields Eye Hospital / UCL BRC

Publications and helpful links

General Publications

• Vickerstaff V, Ambler G, Bunce C, Xing W, Gazzard G; LiGHT Trial Study Group. Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial. Trials. 2015 Nov 11;16:517. doi: 10.1186/s13063-015-1047-9. Erratum In: Trials. 2017 Jul 11;18(1):318.
• Gazzard G, Konstantakopoulou E, Garway-Heath D, Barton K, Wormald R, Morris S, Hunter R, Rubin G, Buszewicz M, Ambler G, Bunce C; LiGHT Trial Study Group. Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology. Br J Ophthalmol. 2018 May;102(5):593-598. doi: 10.1136/bjophthalmol-2017-310877. Epub 2017 Sep 13. Erratum In: Br J Ophthalmol. 2021 Feb;105(2):e1.
• Konstantakopoulou E, Gazzard G, Vickerstaff V, Jiang Y, Nathwani N, Hunter R, Ambler G, Bunce C; LiGHT Trial Study Group. The Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre randomised controlled trial: baseline patient characteristics. Br J Ophthalmol. 2018 May;102(5):599-603. doi: 10.1136/bjophthalmol-2017-310870. Epub 2017 Oct 5.

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): December 25, 2017
• Study Completion (ACTUAL): December 25, 2017

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (ACTUAL): January 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: POAG; Ocular Hypertension; Glaucoma; Laser; Primary Open Angle Glaucoma; SLT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: GAZG1001; HTA 09/104/40 - LiGHT (OTHER: NIHR HTA); ISRCTN 32038223 (OTHER: ISRCTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To supply, upon request and mutually agreed terms, IPD level anonymised data where permitted by local regulations and national law.
• IPD Sharing Time Frame: For as long as is permissible under local regulations and national law.
• IPD Sharing Access Criteria: To Be Confirmed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR